Compliance Officer – US Market

Position: Compliance Officer – US Market

Location: Remote — must maintain at least 3 hours daily overlap with U.S. Eastern Time (GMT-4/-5)

Type: Contract

About the Company

Bridge Business Support Services is leading the delivery of a cutting-edge, FDA-cGMP artemisinin manufacturing line -combining continuous photochemistry, crystallization, and solvent recovery at industrial scale.

Responsibilities:

• Ensure all engineering, procurement, and pilot operations comply with US FDA cGMP, 21 CFR Part 11, ICH guidelines.
• Develop and maintain compliance frameworks for documentation, vendor qualification, audits.
• Review engineering documents (PFDs, P&IDs, equipment datasheets) for regulatory alignment.
• Prepare and support qualification protocols (IQ/OQ/PQ) for equipment and systems.
• Coordinate with vendors and internal teams to ensure regulatory-ready procurement & installation.
• Support preparation of regulatory submissions (DMFs, CMC sections).
• Conduct internal audits and prepare teams for external audits (FDA, clients).

Qualifications & Skills:

• B.E./B.Tech (Chemical/Pharma/Mechanical/Instrumentation) or M.Pharm with compliance specialization.
• 6–8 years’ experience in pharma/biotech compliance (regulatory, QA, or engineering compliance).
• Strong knowledge of US FDA, ICH, EMA regulatory frameworks.
• Experience in equipment qualification, vendor audits, GMP documentation.

What We Offer

• Salary paid in USD
• Remote work flexibility
• Performance-based bonuses and growth opportunities
• Collaborative, startup-style work environment
• Access to learning, tools, and mentorship to boost your career